DIVISION OF RESEARCH INTEGRITY

Human Subjects

Contact Information FAQs Get Started! ------------------------------------ NU Institutional Review Board(IRB) Assurances and IRB Registration Belmont Report and 45 CFR 46 NIH Educational Requirements Training and Educational Resources ------------------------------------ Policies & Procedures - updated Forms & Instructions - updated Informed Consent - updated Modifications to an Approved Protocol

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Contact Information for Investigators

Contact Information for Research Participants

If you have any questions about your rights as a research participant, please contact: Human Subject Research Protection, Division of Research Integrity, 413 Lake Hall, Northeastern University, Boston, MA 02115, Tel. 617-373-7570. You may call anonymously if you wish.

For a list of questions to consider asking before volunteering to participate as a research subject, please visit the U.S. Dept. of Health & Human Services' Office for Human Research Protections public outreach web site.

FAQs

• Are you conducting research with human subjects, such as clinical testing, surveys, human tissue studies, etc.?
• What research requires review by the Northeastern University Institutional Review Board (NUIRB)?
• My research is not federally funded. Do the federal regulations governing research still apply to it?
• Are you seeking funding from the National Institutes of Health (NIH)?
• How do I get started?
• How do I get approval for my research?
• How long does it take to get approval?
• I need my protocol approved right away. Can it be "expedited"?
• May I begin recruitment of subjects while approval of my protocol is pending?
• May I make changes to the protocol after it has been approved?
• How long is the approval valid?
• Who do I contact with questions about my rights as a research participant?

Are you conducting research with human subjects, such as clinical testing, surveys, human tissue studies, etc.?

If you are, be aware that Title 45 Code of Federal Regulations Part 46.102(f) defines a "human subject" as a living individual about whom an investigator obtains:

1. data through intervention or interaction with the individual, (such as, interviews, surveys, clinical testing, or any other physical intervention or personal interaction), or,
2. identifiable private information.

(Private information includes information such as medical records, blood, urine, or tissue samples, diagnostic specimens, and DNA samples, even if you did not collect these materials.)

Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. Protections are required for research that uses:

• Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials.
• Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research.
• Private information, such as medical information that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals fall into this category.

What research requires review by the Northeastern University Institutional Review Board (NU IRB)?

All research involving human subjects, as described above, that is conducted by faculty, staff or students of Northeastern University, whether conducted on-campus or off-campus, requires review. Research that uses any NU property or non-public information to identify or contact prospective subjects must be reviewed and approved prior to recruiting participants or collecting data. Approval by NU is required in addition to approval from any other institution.

My research is not federally funded. Do the federal regulations governing research still apply to it?

Yes. Northeastern University has elected to apply the protections of the federal regulations (45 CFR 46) to all of our human subject research regardless of its source of support, or lack thereof.

Are you seeking funding from the National Institutes of Health (NIH)?

Northeastern University investigators seeking funding from NIH must satisfy the NIH training requirement before an approved study may be initiated. The NIH Office of Extramural Research web-based tutorial "Protecting Human Research Participants" satisfies the human subjects training requirement for obtaining Federal Funds.

Investigators must include a copy of the certificate of completion for this web-based tutorial with their protocol submissions.

How do I get approval for my research?

Read the Policies and Procedures Concerning the Protection of Human Subjects and the application forms to understand your responsibilities as an investigator. Once you have submitted your application, a review will be conducted to ensure that your study has documented procedures in place, in accordance with federal guidelines, that provide adequate protection for each study subject.

How long does it take to get approval?

Investigators are responsible for allowing a minimum of four weeks for the review process. (This means that you should apply at least one month before your anticipated start date.) The NU IRB meets monthly to review protocols. Depending upon the nature of the research, some studies may be reviewed and approved independently by the Chair of the NU IRB. Other studies may require review by the full committee.

I need my protocol approved right away. Can it be "expedited"?

Expedited doesn't necessarily mean "quick". Expedited review refers to a process of review for certain research that falls within categories established by federal regulations. If a protocol meets the specific qualifications for Expedited review, it will not require review by the full Human Subjects Research Review Committee. Instead, the proposed research may be reviewed and approved by the Chair of IRB. Please note that Expedited research still undergoes complete review and a minimum of three weeks is required. Investigators are responsible for allowing sufficient time for review.

May I begin recruitment of subjects while approval of my protocol is pending?

NO. Full approval by DRI is necessary before any recruitment or enrollment procedures may begin.

May I make changes to the protocol after it has been approved?

Yes, BUT, prior to making any changes to the approved protocol and informed consent, you must obtain formal written approval from the NU IRB.

Please submit all requests for modifications to an approved protocol or informed consent in writing to the NU IRB.

How long is the approval valid?

Federal regulations stipulate that approved research requires continuing NU IRB review at least once a year. It is the responsibility of the investigator to request renewed approval, allowing sufficient time for review. If the renewal process is not completed by the expiration date, the project loses approval and the study cannot continue.

Belmont Report and Code of Federal Regulations

Investigators must assure that each member of the research team carries out all research procedures in accordance with ethical principles of research. These principles of Justice, Autonomy and Beneficence were set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," known more commonly as the Belmont Report, and codified as regulations in Title 45 Code of Federal Regulations Part 46.

Northeastern University has a Federal Wide Assurance (FWA #00004630), which is approved by the U.S. Department of Health & Human Services. This is a requirement in order to receive federal funding for research with human participants. The University has elected to apply the protections of the federal regulations (45 CFR 46) to all of our human subject research regardless of its source of support, or lack thereof.

Investigators are strongly encouraged to read these and other relevant documents available at the National Institutes of Health Office of Human Subjects Research Regulations and Ethical Guidelines web site.

As an integral part of ethical conduct of research, federal guidelines require an independent review of protocols involving human subjects before an investigator can begin the study. This independent review process provides an unbiased evaluation of the risks, promotes the safety of research participants and documents that the research, when conducted as approved, will be in accordance with federal regulations. At Northeastern, the Division of Research Integrity and the Institutional Review Board (IRB) serve this independent review function.

It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University's Institutional Review Board (IRB).

NIH Educational Requirements

In October 2000, the National Institutes of Health began requiring more education for all investigators who:

• submit NIH applications for grants
• submit proposals for contracts
• receive new or non-competing awards for research involving human subjects

To comply with this policy, Northeastern University investigators are required to complete the NIH training requirement for obtaining federal funds before an approved study may be initiated. The NIH Office of Extramural Research web-based tutorial Protecting Human Research Participants (PHRP) can be accessed at the following URL: http://phrp.nihtraining.com.

Investigators must include a copy of the certificate of completion for this web-based tutorial with their protocol submissions.

last update: Thursday, September 4, 2008